CO8 - One-year follow up of the PREDMETH trial; a randomized controlled trial comparing prednisone with methotrexate in pulmonary sarcoidosis
Friso de Weert (Netherlands)1; Marlies Wijsenbeek (Netherlands)1; Montse Janssen Bonás (Netherlands)2; Jan C. Grutters (Netherlands)2 3; Rémy L.M. Mostard (Netherlands)4; Henricus N.A.J. van Rijswijk (Netherlands)5; Jan van der Maten (Netherlands)6; Kelly M.C. van Doorn (Netherlands)7; Linda A.A. Moonen (Netherlands)8; Maria J. Overbeek (Netherlands)9; Bart Koopman (Netherlands)10; Marco Grootenboers (Netherlands)11; Esther J. Nossent (Netherlands)12; Michiel Wagenaar (Netherlands)13; Henk Kramer (Netherlands)14; Eveline Schakenraad (Netherlands)15; Peter I. Bonta (Netherlands)12; Stefan Walen (Netherlands)16; Chantal Knoops (Netherlands)17; Mayka Overgaauw (Netherlands)18; Marcel Veltkamp (Netherlands)2 3; Catharina C. Moor (Netherlands)1; Vivienne Kahlmann (Netherlands)1 7;
1 - Centre of Excellence for Interstitial Lung Diseases and Sarcoidosis, Department of Respiratory Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands; 2 - Interstitial Lung Disease Center of Excellence (member of the European Reference Network on Rare Respiratory Diseases), St. Antonius Hospital, Nieuwegein, the Netherlands; 3 - Division of Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands; 4 - Department of Respiratory Medicine, Zuyderland Medical Center, Heerlen, the Netherlands; Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, the Netherlands; 5 - Department of Pulmonary Medicine, Jeroen Bosch Hospital, ’s-Hertogenbosch, the Netherlands; 6 - Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, the Netherlands; 7 - Department of Pulmonology, Leiden University Medical Center, Leiden, the Netherlands; 8 - Department of Pulmonary Medicine, Rijnstate Hospital, Arnhem, the Netherlands; 9 - Department of Pulmonary Medicine, Haaglanden Medical Center, The Hague, the Netherlands; 10 - Department of Pulmonary Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; 11 - Department of Pulmonary Medicine, Amphia Hospital, Breda, the Netherlands; 12 - Center of Expertise for Interstitial Lung Disease and Sarcoidosis, Department of Pulmonary Medicine, Amsterdam University Medical Center, Amsterdam, the Netherlands; 13 - Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands; 14 - Department of Pulmonary Medicine, Martini Hospital, Groningen, the Netherlands; 15 - Department of Pulmonary Medicine, Catharina Hospital, Eindhoven, the Netherlands; 16 - Department of Pulmonary Medicine, Isala Hospital, Zwolle, the Netherlands; 17 - Department of Pulmonary Diseases, VieCuri Medical Center, Venlo, the Netherlands; 18 - Sarcoidosis Patient Association, Alkmaar, the Netherlands;
Keywords: Prednisone; Methotrexate; Treatment;
Select the theme: Controversies in Sarcoidosis Treatment
Type: Original Papers
Presentation: Oral Communication
Introduction: The PREDMETH trial showed that methotrexate was non-inferior to prednisone in terms of change in forced vital capacity (FVC) after 24 weeks of treatment. Predefined treatment schedules were followed up to 24 weeks. Thereafter, treatment decisions were made at the discretion of the treating physician in shared decision making with the patient.
Objectives: To evaluate FVC outcomes and medication use in the PREDMETH trial at 1 year.
Materials and Methods: FVC and medication-use data were collected at 1 year. The unadjusted mean change in percentage predicted (%pred) FVC from baseline to 1 year were calculated for each group. Between-group differences in change in %pred FVC at 1 year were calculated using linear mixed-effects models, adjusted for baseline FVC. Medication use was described and visualized in a Sankey diagram.
Results: Of the 138 patients, FVC data were available for 131 and complete medication-use data for 134 patients, at 1 year. At 1 year, the mean change in FVC was 9.1% (SD 8.8) in the methotrexate group and 8.5% (SD 9.5) in the prednisone group compared to baseline (Figure 1). The adjusted between-group differences in change from baseline was –0.02% (95% CI, -3.05 to 3.02). At 1 year, 30 (44.1%) of the 68 patients initially assigned to prednisone continued using prednisone monotherapy, whereas 14 (20.6%) switched to combination therapy with methotrexate. In the methotrexate group 44 (66.7%) of the 66 patients continued using methotrexate monotherapy, 9 (13.6%) switched to combination therapy. In total, 5 patients switched to third-line therapy (Figure 2).
Conclusions: One year follow-up data from the PREDMETH trial demonstrated sustained improvement in both the prednisone and methotrexate group. After the predefined treatment period of 24 weeks, treatment strategies became heterogeneous, with treatment switches occurring more frequently in the prednisone group than in the methotrexate group.